Submission communications & appeal by country

The applicant may file a written appeal with the Ministry of Health against refusal of registration, amendment or cancellation in the National Register of Medical Devices; ministerial licensing decisions are appealable under Article 30 of Law No. 10081/2009 on licences, authorizations and permits; appeals against measures under the law follow the inspection legislation.

After an online application, responsible officers verify the documentation and the applicant is notified by e mail and in the 'Dokumentet e mia' section of their e Albania account about additional documents to be completed, issuance of the registration certificate, or the official justification for non issuance of the requested document.

Against a rejection of an export only homologation application, the establishment may file a recourse (recours) with ANPP within 30 days of notification of the rejection decision; for modifications, a corrected application addressing the rejection motives may be filed within 30 days of receipt, decided within 30 days.

A homologation application is refused after commission opinion on defined grounds (altered characteristics/performance, non conformity with the dossier, unfavourable safety report, inadequate manufacturing/control processes, insufficient documentation); any refusal notified by the ANPP Director General must be motivated.

ANPP Note N°39 2026 of 22 April 2026 governs the lifting of reservations raised on device homologation dossiers; Note N°47 2025 of 4 December 2025 governs the payment proof documents due for registration and device homologation requests.

The recurso jerárquico (hierarchical appeal) must be filed before the authority that issued the challenged act within 30 days; acts of autarchic entities such as ANMAT may also be challenged by recurso de alzada before the Ministerio de Salud.

A party may file a recurso de reconsideración (reconsideration appeal) against an ANMAT act within 20 days of notification, under the national administrative procedure regulation applicable to ANMAT decisions.

The grounds for refusing to grant the import (conformity) certificate are: (1) failure to comply with the requirements established by the Law; (2) incomplete, manifestly false or distorted data or documents, or the absence of one of the documents required by legislation and failure to file them or to remedy the deficiencies within the established period; (3) mismatch between the data of the imported product and the documents accompanying it; (4) absence or non conformity with the registered particulars of special warnings in the packaging entries of the imported product; (5) non conformity of the imported product's instructions for use with the registered ones; (6) submission of an application drawn up in violation of the requirements established by the Law; (7) mismatch between the information submitted by the applicant and the information the authorised body received in the framework of interstate and interdepartmental cooperation; (8) the absence of Armenian state registration of the imported medical device, except in the cases established by the Law; (9) expiry of the imported product; (10) violation of the special conditions of transport and storage of the device or absence of reliable data on storage.

External merits review is now conducted by the Administrative Review Tribunal (ART), which replaced the Administrative Appeals Tribunal (AAT); all cases before the AAT immediately prior to 14 October 2024 were automatically transferred to the ART.

A person dissatisfied with a Ministerial reconsideration decision may apply to the Administrative Review Tribunal (ART) for merits review; the application must be made in writing within 28 days after the day notice of the reconsideration decision is given, subject to the Administrative Review Tribunal Act 2024.

A person whose interests are affected by a reviewable initial decision may request the Minister for Health to reconsider it under s 60 of the Act (or reg 48 TG Regs 1990 / reg 10.7 MD Regs 2002); requests incur no fee and must generally be made within 90 calendar days of notice; if no decision issues within 60 days the initial decision is taken to be confirmed. Preliminary assessment refusals and s 41FH audit selection or s 41JA information request decisions are not reviewable.

A decision of BASG or of another Austrian authority on a medical device is a Bescheid, so it is challenged by Beschwerde to the administrative court. VwGVG § 7(4) gives four weeks from Zustellung, or from Verkündung where the Bescheid was only announced orally, against a Bescheid under Art. 130 Abs. 1 Z 1 B VG. Procedural orders in the administrative procedure cannot be challenged separately; they can only be attacked in the Beschwerde against the decision that disposes of the matter (§ 7(1)). A party that has expressly waived Beschwerde after Zustellung or Verkündung may not bring one (§ 7(2)).

After an ethics committee application arrives, the committee must check whether it is in order and tell the sponsor immediately, and at the latest within five working days of receipt (MPG 2021 § 19(2)). A reasoned opinion is then due within 35 days of the sitting deadline the committee publishes a year in advance (§ 19(1) and (5)). During examination the committee may demand additional information or the cure of defects, and the 35 day period starts afresh from the next sitting deadline after that information arrives (§ 19(6)). Independently of the MPG, AVG 1991 § 13(3) forbids an authority from rejecting a written filing for defects: it must of its own motion prompt their cure without delay, may set a reasonable period after which a fruitless filing is rejected, and a timely cure treats the filing as originally correct. Urgent inspection measures that BASG takes without a prior procedure or Bescheid must be followed by a written Bescheid within two weeks or they lapse (§ 31(5)); urgent market safety measures under § 44(1) must be followed by a written Bescheid within four weeks.

If the applicant does not cure the notified deficiencies within 10 working days, the Ministry adopts an administrative act leaving the application unexamined and informs the applicant within 2 (two) working days, by delivery or registered post (§7.5). After curing the deficiencies the applicant may apply again with a fresh application for the registration certificate (§7.6). Registration, re registration and variation applications are refused where the Part 3/Part 4 documents are not submitted in full and the deficiency is not cured under Article 52 of the Law on Administrative Proceedings (§5.1.1), where information submitted is found to be untrue (§5.1.2), and, for a medical device, where an inconsistency is found in the submitted documents concerning the device's quality, effectiveness and safety (§5.1.4); a refusal decision is notified to the applicant by registered post within 2 working days (§5.2).

If a Bahraini registration application does not fulfil all requirements it is returned with the recommended action; the applicant has two further submission attempts without repaying the application fee, and if the third submission still fails the application is rejected and the fee must be paid again. Where a rejection or return can be justified without new documents, the applicant has 10 working days to submit an appeal with justification. Classification requests likewise allow up to three resubmissions before a new fee is due.

Where registration is suspended and production/marketing halted, the person or establishment may, within 30 working days, apply to the Licensing Authority for reconsideration of the order or file an appeal with the Government; parties must be given a hearing, and the decision of the Licensing Authority or the Government is final.

The Ministry of Health's commission on medical products handles applicants' disagreements with RUP CEIZ conformity conclusions and product qualification questions. Refusal of registration (reregistration) is only possible on grounds of the Law 'On the Basics of Administrative Procedures' № 433 З or where the same device is already registered by another applicant under the same trade name or required documents were not provided; decisions are taken by ministerial order and communicated within 5 working days.

A sponsor may lodge a gracious appeal (recours gracieux) with the minister or their delegate against refusal of a clinical investigation authorisation, within thirty days of publication of the refusal. The minister seeks the opinions of FAMHP and of a different ethics committee; under the 2026 amendment the minister must decide within three months, and authorisation requires both favourable opinions.

statement: Where the unit responsible for registration does not approve the product, it notifies the interested party, who has the right to file a recurso de reconsideración within the following 15 working days. The notification states the grounds for non approval. · article: Art. 17

statement: Where a device dossier is observed for a remediable technical point, the interested party is given a note detailing the observations, which must be remedied within 60 calendar days by submitting the corresponding documentation together with the note received; the file is returned to the interested party only in exceptional cases and on written request. Where the dossier is rejected for missing documents, it is returned to the interested party and may re enter for a second evaluation within no more than 60 calendar days, attaching a copy of the payment order for the second evaluation. · article: Numeral 3.1.4(b) and (c)

No appeal is permitted against the Agency's certificate of entry in the Register of medical devices; an administrative dispute may however be brought (Član 65. stav (9)). The same applies to the Agency's conclusion (zaključak) on the categorisation of a medical device (Član 73. stav (3)). The Agency also issues expert opinions and answers to queries on request, with a limited validity of one year from the date of issue (Član 74). Separately, under Zakon 58/08 Član 118. stav (2) the Agency's decision refusing registration of a clinical investigation is final in the administrative procedure, with no appeal but an administrative dispute before the competent court.

Any person aggrieved by a decision of the Authority on an application for registration of a medical device may make representations in writing to BoMRA and follow the appeal process stipulated in the Medicines and Related Substances Act or its regulations. The import/export guideline provides a parallel review and appeal route for import or export decisions.

From acts practiced by ANVISA an appeal (recurso) lies to the Diretoria Colegiada, with suspensive effect, as the last administrative instance (Lei 9.782/1999 Art. 15 §2º); the appeal is filed within 30 days of publication/intimação (§3º) and decided within 90 days, prorrogable (§4º). Under RDC 266/2019 the second instance is the Gerência Geral de Recursos (GGREC) and the last is the Diretoria Colegiada Dicol.

Technical deficiency letters (exigência técnica) under RDC 204/2005 must be answered within 120 days, non extendable, counted from confirmation of receipt of the exigência; non compliance results in refusal (indeferimento) of the petition (Art. 11).

Since 17 February 2021, electronic deficiency letters that would previously be answered in the Sistema de Peticionamento Eletrônico must be answered through the Solicita system.

Section 21 of the Medicines Act gives a person aggrieved by an Authority decision under s. 20 (suspension or cancellation of a medicinal product registration, or suspension, revocation or variation of a licence) a written appeal to the Minister within 14 days of the decision being made known, the Minister's decision being final. No appeal lies against a rejection under s. 14, which may be made without reasons. Because no device application, deficiency or decision process exists, no device communication or appeal route exists.

An applicant dissatisfied with a decision of the Radiation Protection Authority under s. 8 (grant, renewal, conditions, refusal, suspension or cancellation of a licence), s. 14 or s. 15 may appeal to the Minister in writing within 30 days of communication of the decision. The Minister appoints one or more persons to hear the appellant and the Authority, may inspect the premises or controlled apparatus, and may dismiss the appeal, require a licence to be issued, quash or substitute a suspension or cancellation, or vary the decision; the Minister's decision is final.

Refusals under ЗМИ (e.g. refusal of a clinical investigation application) are appealable under the Administrative Procedure Code (Административнопроцесуален кодекс).

Appeals against BDA market surveillance orders do not suspend execution of the contested order.

In a dispute between a Member State and any person over the classification of a medical device, the Regulatory Authority of that Member State decides the proper classification and its decision is final. This is the only express final decision provision retrieved for a device decision; no separate reconsideration or appeal route against a registration decision was located, and the general administrative law remedy for Cambodian administrative decisions is not asserted here because the instrument was not retrieved.

Where the Minister refuses to issue or amend a licence, the applicant must be notified in writing of the reasons for the refusal and be given an opportunity to be heard.

A manufacturer may seek reconsideration of a rejection or refusal decision by filing a request for reconsideration (RR) within 30 days; the Medical Devices Directorate then proceeds by an internal review or an external panel review pathway chosen by the Director General, with the DG reconsideration decision issued within 5 days of receiving recommendations.

Persons whose devices are rejected in the conformity verification by an authorized entity may claim in writing to ISP within 15 working days from communication of the non conformity (Art. 6). Separately, applicants for entity authorization denied or not answered within 30 working days may claim in writing to the Ministry of Health within 15 working days (Art. 14), resolved by founded resolution.

Once evaluation starts, if problems are detected in the submitted documents, the applicant receives an email notification with the details of the observations to be cured; the resolution is notified by email and is available in the 'Trámites Finalizados' section of the user's SAFIS account; queries run through the ISP online OIRS citizen attention platform (siac.ispch.gob.cl).

Applicants who disagree with an approval conclusion on NMPA licensing items may seek administrative reconsideration (行政复议) by NMPA or file administrative litigation (行政诉讼).

Against definitive INVIMA administrative acts, the general administrative remedies are recurso de reposición (filed before the authority that issued the decision) and recurso de apelación (before the immediate administrative or functional superior); both must be filed in writing at personal notification or within 10 days of it; the apelación is required before going to court and may be filed as subsidiary to reposición.

During registration evaluation INVIMA may request additional information only once; the applicant must supply it within 90 days, failing which the petition is deemed withdrawn (desistimiento) with no refund of the fee.

Users of the Regístrelo portal must designate an e mail address as their permanent electronic domicile for receiving notifications on proceedings managed in the system (Art. 14). A notification to the electronic domicile or subsidiary medium takes effect on the business day following its reception, and legal deadlines run from the business day after notification (Art. 15). Regístrelo may additionally communicate the status of each proceeding by e mail or SMS, which does not exempt the user from the duty to track the proceeding in the portal (Art. 16).

For EMB registration the Ministry has up to two months (odontología devices) or four months (microbiología and medicina devices) from receipt of the application to approve it and issue the sanitary registration, or to reject it. No change renewals by sworn declaration are resolved within twenty natural days; renewals with changes within one, two or three months by category; and post registration changes within one month for notification type changes.

The action is introduced by a requête written in French, addressed to the Director General of the AIRP and filed at the Authority's headquarters. It must state the applicant's name, profession, domicile, postal address and telephone contacts (for a legal person: its form, name or company name and the name of its legal representative), the object of the complaint, and a summary of the grounds of fact and law relied on; it must be accompanied by all supporting documents evidencing the dispute and, where lodged through a representative, by the express mandate.

The right to contest an AIRP administrative act is open to any natural or legal person, whether or not an actor of the pharmaceutical sector or a holder of an AIRP authorisation, who shows an interest in acting. Before seising the Conseil d'État with a recours pour excès de pouvoir, the applicant must first make an administrative appeal: first to the author of the act (recours gracieux) asking for its withdrawal or annulment, and, if unsatisfied, to the hierarchical superior of the author (recours hiérarchique).

The administrative appeal against an AIRP act, whether gracieux or hiérarchique, must be lodged within two months. For individual acts the period runs from notification to the person concerned; for regulatory or collective acts it runs from publication as regards third parties.

Proceedings under the Croatian implementing act are conducted under the general administrative procedure law. Against acts of the competent authority no appeal is allowed, but an administrative dispute may be initiated. This applies to the Agency's decisions on entry in the register of distributors, on classification disputes, on registration of economic operators, on derogation approvals and on refusals of clinical investigation approval, since the act repeats the rule for each of those procedures.

If the conformity assessment process ends in denial of the Registro Sanitario, the manufacturer is notified with the evaluation report stating the grounds; the manufacturer may not file a new registration application for the device in question until 6 months have passed.

An interested party aggrieved by a final decision or sanction applied by CECMED may request Reconsideración of the measure before the Director General of CECMED, under the CECMED regulation 'Quejas, Reclamaciones y Reconsideración de Decisiones Reguladoras'; if the disagreement persists after CECMED's response, the party may file a Recurso de Apelación before the Minister of Public Health within the term set by that authority's rule.

Notification to the Cypriot competent authority is made by e mail: a person placing medical devices on the Cypriot market must notify the Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA) by sending the completed Excel notification file to cymda@mphs.moh.gov.cy. The authority's acts are administrative acts and are reviewable: Article 146 of the Constitution guarantees the right of recourse against administrative acts, which since the Eighth Amendment of the Constitution (Law 130(I)/2015) lies at first instance exclusively with the Administrative Court established by the Law on the Establishment and Functioning of an Administrative Court of 2015 (Law 131(I)/2015). The deadline is strict and non extendable: 75 days from the day of publication of the act or decision where publication is required by law or, for an unpublished act or omission, from the day it comes to the applicant's knowledge. An appeal against a judgment of first instance of the Administrative Court lies to the Supreme Court within 42 days of the date of issuance of the judgment.

SÚKL issues a decision on preventive (safeguard) measures under MDR Art. 98 / IVDR Art. 93; an appeal against this decision has no suspensive effect.

The minister may set rules on appeal of notified body decisions and of DKMA decisions under the device act and under the EU device regulations, including rules that named DKMA decisions cannot be appealed to another administrative authority (LBK 682/2023 § 4). BEK 1731/2025, made under that act, does not exercise the cut off. A written decision that can be appealed to another administrative authority must carry klagevejledning stating the appeal body, how to appeal and any time limit (Forvaltningsloven § 25(1)), unless the party is given full satisfaction. The device act and BEK 1731 themselves do not publish a klagefrist.

Before DKMA decides a device matter on facts or external expert assessments that are unfavourable to the party and of material importance, and that the party cannot be assumed to know the agency already holds, it must make those materials known and give the party a chance to comment, and it may set a deadline for that comment (Forvaltningsloven § 19(1)). A party may also, at any point in the case, require the decision to wait until it has commented, again subject to an authority set deadline (§ 21(1)). Neither right applies where waiting would overrun a statutory decision period. The agency must also give guidance to a person who approaches it on a matter in its field (§ 7(1)). BEK 1731/2025, which is the current national device regulation, contains no separate deficiency cure clock of its own, so these Forvaltningsloven rules are the national communication layer around a DKMA filing.

statement: Administrative acts that end a procedure, prevent its continuation, produce defenselessness, harm subjective rights or cause irreparable damage may be challenged directly by the administrative route. The person may file a recurso de reconsideración before the organ that issued the act, which must decide within thirty days, and a recurso jerárquico before the competent Minister — in the central administration — without needing to have filed a reconsideración first, which must equally be decided within thirty days. If either appeal is not decided within the period, the interested party may treat it as tacitly denied and go, at its option, to the contentious administrative jurisdiction without a preclusive deadline. Administrative appeals are optional, and filing one does not suspend the challenged act, although the reviewing organ may order its suspension of its own motion or on request. · article: Arts. 47, 49, 50, 51, 53 y 54

statement: A sanitary registration application for a sanitary product is prepared from DIGEMAPS's published requirements list and filed online or in person at the Dirección de Gestión de Servicios al Usuario of the Ministerio de Salud Pública. That directorate confirms whether the application is complete — accepting it if it is, and notifying the applicant of the missing data or documentation if it is not — and the application is then entered and sent to DIGEMAPS for evaluation in the corresponding area, with the answer returned through the same directorate for delivery to the applicant. An application that was found non conforming may be re entered once the applicant has completed the observations received. · article: Procedimiento a seguir

Deficiencies are handled by returning the file (trámite) to the applicant for cure: documentary stage objections get one 5 day cure window (2026 regime) or correction rounds under the current 2016 regime; post technical evaluation objections get cure rounds (30 days national / 60 days foreign under the 2026 regime; 30 days with max two rectifications under the 2016 regime). Failure to cure or to pay within the window leads to automatic cancellation with status 'solicitud no aprobada'; a new application with new fee payment is then required and the paid inscription/modification fee is not reimbursed (Art. 18).

Applicants may appeal a Scientific Committee or Import Committee rejection by submitting new documents not previously presented or a scientific explanation of the rejection points.

Requirements are sent to the company by e mail/platform and must be fulfilled within 60 working days (registration workflow); suspended files are completed on the platform under the same request number, hard copy submission may be scheduled for variations, and rejected requests state the mismatch grounds (data vs payment receipt/required documents or wrong department).

There is no device specific appeal route in Estonian medical device law. The Medical Devices Act's own challenge provision, § 37 'Ettekirjutuse ja toimingu vaidlustamine' (challenge of a precept and of a measure), is repealed, and § 2(2) of the Act provides that the Administrative Procedure Act applies to the administrative procedure provided for in the Medical Devices Act, taking account of the Act's derogations. The remedy is therefore the general administrative law one. A person who considers that an administrative act, or a step taken in the course of administrative proceedings, has infringed that person's rights or restricted that person's freedoms may file a challenge (vaie) under § 71(1) of the Administrative Procedure Act. Unless the law provides for a different venue for challenges, the challenge is filed through the administrative body that issued the act or performed the measure, addressed to the body that exercises service supervision over it (§ 73(1)); where that supervising body is a minister, as for Ravimiamet, the challenge is decided by the body that issued the act itself unless a law provides otherwise (§ 73(3)). The challenge must be filed within 30 days, unless a law provides otherwise, counting from the day the person learned of, or should have learned of, the challenged administrative act or measure (§ 75). A person whose challenge was not satisfied, or whose rights were infringed in the challenge proceedings, may apply to the administrative court by appeal under the conditions and procedure laid down in the Code of Administrative Court Procedure (§ 87(1)).

Applicants can request a review of a decision or appeal their complaints after a market authorization certificate is granted, in accordance with the complaint handling procedure set by the Authority. If an applicant wishes to request correction of a market authorization certificate, the request must be made within one month from the date of issuance of the certificate, and no certificate will be corrected if the request is made later than one month after issuance.

EFDA's device dossier assessment model is that the review is completed on the basis of the information submitted, a list of questions is then sent to the applicant setting a specified time limit for response, and a number of further rounds of assessment of the responses take place before a decision is made. An application is rejected at screening or evaluation if it is found to be unsatisfactory after evaluating the response to the third further information request, or if the applicant fails to respond to a request to fulfil required documents or information after screening or evaluation within 6 months from the date of the request. Rejection also follows if the requested actual samples for laboratory testing have not been provided within 6 months of request, if submitted documents are found fake or owned by another company, if the route of application is wrong (for example applying non IVD as IVD or non SRA as SRA), or if the device is already registered or another submission for the same device is pending by the same or another applicant.

Where a clinical investigation application is incomplete or out of scope, the Member State informs the sponsor and sets a maximum 10 day limit (extendable by 20 days) to comment or complete via the electronic system; if the sponsor does not respond in time the application is deemed to have lapsed; if the sponsor disputes the Member State's view the application is treated as rejected, and the Member State concerned shall provide an appeal procedure (Art. 70(3) MDR). Refusals of authorisation after assessment likewise carry a Member State appeal procedure (Art. 71(4) second subpara MDR). There is no EU level appeal forum against notified body decisions; NBs must operate complaints and appeals procedures under their QMS (Annex VII MDR) and Member States lay down penalties (Art. 113 MDR).

A decision made by Fimea or a notified body under MDR, IVDR or the national act may be challenged by seeking rectification (oikaisu) as provided in the Administrative Procedure Act; appeal to an administrative court is governed by the Act on Judicial Procedure in Administrative Matters (808/2019).

ANSM is the responsible authority for notified bodies under Article 35 of Regulations (EU) 2017/745 and 2017/746, handling their evaluation, designation, re assessment and joint assessments with EU experts; recourse concerning notified body oversight in France therefore lies with ANSM, which is confirmed as competent authority including for classification disputes (MDR Art. 51(2), Art. R5211 5 CSP).

If the Agency refuses to register a product it must immediately give the interested person written notice of a reasoned refusal. If the interested person is not notified of a decision not to register within the statutory period, the product is considered registered and the Agency is obliged to issue the document confirming marketing authorisation in Georgia; that document is formalised within 10 days after the administrative act on registration. The administrative act and the marketing authorisation document are equivalent documents.

A decision of BfArM or of a Land authority on a medical device is an administrative act, so before an action to set it aside its lawfulness and expediency are re examined in a preliminary procedure (VwGO §68(1)); that preliminary procedure is dispensed with where a statute so provides, where the act was issued by a supreme federal or supreme Land authority, or where the remedial or objection decision is the first to impose a burden. The objection must be lodged in writing, electronically or on the record within one month of the act being notified to the person burdened, with the authority that issued it (VwGO §70(1)). The action must then be brought within one month of service of the objection decision, or within one month of notification of the act where no objection decision is required (VwGO §74(1)). §68(2) and §74(2) apply the same scheme to an action to compel a decision where the application was refused, which is the route against a refused authorisation.

Where documents are missing without justification or the application is otherwise not in order, the competent ethics committee calls on the sponsor to cure the named defects within ten days and must state in that request that the §36 period only begins once a proper application has arrived (MPDG §34(2)); receipt of a proper application is confirmed within ten days with the date of receipt (§34(3)). The opinion is then due within 30 days of that receipt (§36(1)), the period is suspended from despatch of a request for additional information until the information arrives (§36(2)), and it extends by 15 days where the committee takes expert advice, which must be notified to the sponsor no later than 20 days after receipt (§36(3)). Protocol changes the sponsor makes during the procedure to clear the federal authority's objections must be notified through DMIDS and count as approved if the ethics committee does not object within 14 days (§39(2)). A refusal of a substantial modification must reach the sponsor within 37 days of the notification, extended by seven days where expert advice is taken, again with a 20 day notice duty (§42).

In the event of rejection of a clinical trial application, the applicant may appeal to the Minister of Health within sixty days in writing, giving grounds for review; absent a representation within that period the Authority's decision stands.

Where the Authority refuses registration or approves it subject to conditions, the Chief Executive Officer shall inform the applicant in writing of the decision and the reasons within thirty days of the refusal or approval.

An applicant not satisfied with a registration decision may make representations to the Authority within sixty days after notification; if the Authority remains unsatisfied it shall reject the application.

Responses to all queries in a deferral letter must be provided in one submission; if queries are reissued a third time and responses remain unsatisfactory, the application is rejected.

An applicant may withdraw a registration application at any time, but withdrawal does not entitle the applicant to a refund of the application fees.

An individual administrative act must also state whether a special administrative or ενδικοφανής appeal under Art. 25 of Law 2690/1999 is available, name the body that examines it, state the deadline, and state the consequences of not bringing it (Art. 16(1)). An appeal brought in accordance with the information the service itself gave cannot produce consequences against the appellant. Omitting the applied provisions, or omitting those Art. 25 notice elements, does not of itself void the act. The reprint used here does not contain Art. 25, so the numerical length of that deadline is not published in this source and is not asserted.

An individual administrative act of EOF, including a refusal or other adverse device decision, must contain reasoning that records the statutory conditions for issuing it (Law 2690/1999 Art. 17(1)). That reasoning must be clear, specific and adequate and must follow from the file, unless a statute requires it to appear in the body of the act (Art. 17(2)). Where the interested party asks for the act, that party must submit the supporting documents the governing provisions require, unless those materials are already held by the issuing authority (Art. 17(3)). The act is written, names the issuing authority and the provisions applied, and carries a date and the signature of the competent organ (Art. 16(1)). National device instruments do not set a separate deficiency cure clock, so these Code of Administrative Procedure rules are the national communication layer around an EOF filing.

All petitions that involve the issuance of a certification, an authorisation or an opinion are deemed resolved favourably where the competent authority, under the Código de Salud and its regulations, does not issue it within the periods established for that purpose. For an applicant for a device or IVD inscription or authorisation, the practical effect is that a decision not taken within the prescribed period is treated as a favourable one.

In the DRCPFA's procedure for entry and evaluation of related product inscription files (F AA p 01), the applicant submits the application to the DRCPFA and the National Health Laboratory (LNS); the Department evaluates the application and asks whether it complies; where it does not, a deficiency note ('se envía nota de reparo') is sent and the applicant remedies the non conformities ('subsana inconformidades'); where an LNS analysis is required and the analysis does not comply, the application is closed ('se da de baja a la solicitud'), and where it does comply the Inscription Certificate is issued and passed to the Documents Reception and Delivery section for collection.

The LRP is notified of the appeal outcome within four (4) weeks of submission of the appeal and all required supporting information; the Appeal Committee decision is final; lodging an appeal does not suspend the MDD decision unless MDD decides otherwise.

The LRP may appeal against rejection, conditions imposed on a conditional approval, or removal from the List of Medical Devices within fourteen (14) working days of notification; late appeals are not considered.

NNGYK provides a remedy procedure (jogorvoslati eljárás) against rejecting decisions; stated for rejections of clinical investigation applications, e.g. for omitted fee payment.

NNGYK treats the EUDAMED Actor data upload as an application (kérelem) under the general administrative procedure code (2016. évi CL. törvény, Ákr.); deficiencies are communicated by decision (végzés) via cégkapu and are remedied by editing the original APP request in EUDAMED.

Unless the Act provides otherwise, administrative decisions taken on the basis of the Medical Devices Act may be appealed to the minister (the Minister of Health). The right of appeal and the procedure follow the Icelandic Public Administration Act (stjórnsýslulög). This is the appeal route against Lyfjastofnun decisions such as a CE marking exemption refusal, a distributor registration decision, or a market surveillance measure.

An applicant whose import licence application is rejected may appeal to the Central Government within forty five days; the Government decides within ninety days of the appeal. Documents found misleading, fake or fabricated lead to summary rejection after opportunity of hearing (rule 92), with possible debarment (rule 93, appeal within thirty days).

Against a CLA order under rule 43A (suspension, cancellation, stop import or destruction of an import licence), the aggrieved person may appeal to the Central Government within thirty days of service of the order.

Applicants receive notification of the izin edar issuance or the digitally signed rejection letter by e mail and SMS to the registered company contact, and download the license or rejection letter electronically via regalkes.kemkes.go.id. Applications failing safety/quality/benefit requirements receive a rejection letter; the paid PNBP fee is not refunded for rejected applications.

All steps of application, tracking and issuance of the manufacturing license are electronic; the official service charter shows the internet channel (through imed.ir) as the sole enabled service channel.

Questions on tracking label XML files are submitted as tickets to the FDA support system at support.ttac.ir (section 'مشکلات فایل‌های شناسه رهگیری و ردیابی (XML)') and are answered within 48 hours.

For a medical appliance supply contract awarded in Iraq, the Contracting Entity must respond immediately and in writing to any bidder who submits an inquiry to the contracting authority about the reasons for not choosing its bid, after receiving notification of the award decision. The notification of award forms the contract only subject to settlement of an unsuccessful bidder's appeal, and the mechanism used in considering bidders' complaints is the instructions for the implementation of the general government contracts in force. The Contracting Entity sends the contract form only after the standstill period and settlement of appeals, and where an appeal is pending it still has the right to proceed with the successful bidder upon finding that the contract is fully compliant and that it is in the public interest not to delay commencement.

A sponsor may appeal HPRA decisions within 28 days of receipt: refusal of clinical investigation authorisation (MDR Art. 70(3)), decisions under Art. 71(4), and refusal of substantial modification authorisation (Art. 75(3)(a)); HPRA publishes guidelines on appeal procedures.

HPRA appeals for clinical investigation objections (and clinical trial non acceptances) are submitted to the relevant statutory Advisory Committee within 28 days of notification and decided by the Authority (the nine HPRA members); classification decisions are appealed to the HPRA Leadership Team. HPRA states only classification decisions and objections to clinical trials and clinical investigations are appealable, and an appeal fee applies per the Guide to Fees.

IVD performance study decisions may be appealed to HPRA not later than 30 days after notice of the decision: Article 66(3) authorisation refusals, decisions under Article 67(4), and refusal of authorisation for a substantial modification under Article 71(3)(a).

An application may be transferred from the regular track to the fast track via a cover letter requesting the transfer, a signed affidavit and an updated marketing data document. Document requirements are identical across tracks; the difference is the required declaration document (fast track requires a lawyer affirmed affidavit). If no intake confirmation arrives within 7 days, the application must be resent.

Before adoption of any denial or restriction measure (including clinical investigation measures, bans or limitations on placing on the market, making available, withdrawal or recall), the addressee, where identified or identifiable, must be invited to present counter arguments (controdeduzioni), unless urgency makes this impossible; every such measure must be motivated (Art. 20(1)).

Denial and restriction measures (including urgent ones) are notified to the interested party with an indication of the deadline within which an appeal (ricorso) may be brought.

Where the reduced payment of an administrative sanction has not been made, the authority competent to receive the report under Art. 17 of Law 689/1981 is the Prefetto (Prefect); sanctions are ascertained by the surveillance organs and Ministry of Health offices per their competences (Art. 27(49)), and Law 689/1981 Chapter I applies for matters not covered (Art. 27(52)).

In case of serious risk to public health, the Ministry adopts measures urgently without prior counter arguments; the measures are notified to the addressee together with the grounds and a deadline of no more than 30 days to present elements unequivocally proving the device's conformity; if the 30 days lapse unfulfilled or the elements are insufficient, the Ministry notifies the finality of the measure by reasoned act (Art. 20(4)).

Applicants can file a formal appeal (審査請求) with MHLW against PMDA dispositions (other than review results) or inaction in medical device reviews; MHLW is treated as PMDA's superior agency for the appeal.

The Objections Committee (chaired by the Director General) reviews objections to decisions issued under the Law and must decide within one month of filing the objection; its decisions are final.

The responsible pharmacist or authorized person may object to any decision issued under Testing Regulation 41/2024 before the Objections Committee (formed under Art. 13 of the Law) within 30 days of being notified of the decision, attaching grounds and supporting documents.

Before a negative decision the services provider holds a hearing under Art. 73 of the Administrative Procedural Processual Code, notifying the applicant at least 3 working days in advance; the applicant may submit an objection to the preliminary decision no later than 2 working days after receipt.

The applicant must answer the authority's query within 60 working days of receipt; the query period is excluded from the authority's procedural timelines.

Under the 2026 single window registration rules the review timeline is suspended while the applicant cures deficiencies noted in the documents; on additional questions the applicant answers within 25 working days (expertise rules for devices).

Under section 42B of the Pharmacy and Poisons Act, appeals against specified decisions (under ss. 27(2), 28(3), 32(5), 50(2)) shall be in writing and lodged within thirty days after the date of the act appealed against; certain refusals/revocations under s.27(2) lie to the Cabinet Secretary, whose decision is final.

Under rule 5(5) of the 2022 Registration Rules the Board may only reject an application after providing the applicant an opportunity to be heard, and must inform the applicant of the reasons for rejection in writing; under rule 11(3) the Board must give notice and an opportunity to be heard before suspension or cancellation of a certificate.

statement: Administrative acts issued by the director of the State Agency of Medicines (other than the decision referred to in paragraph 8 about officials' decisions) and actual action may be contested before the Ministry of Health; the Ministry's decision may then be appealed to the administrative court. Decisions and actual action of officials of the agency's structural units may be contested by submitting an application to the director of the agency, and the director's decision may be appealed to the administrative court. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

Once the assessment of the file is complete the health technology unit issues an opinion based on the information supplied and on its findings, which is transmitted to the Minister of Health for the issue of the final decision. Where the application is incomplete the unit may go back to the applicant to request supplementary information, indicating a deadline for the response. Each registration application receives its own reception order number, used as the common reference for all subsequent exchanges between the applicant and the MOPH.

The Ministry of Public Health may, on the report of the health technology unit, refuse, provisionally suspend or withdraw the registration certificate of the medical device concerned. The holder has a period of 60 days from the date of notification of the decision to regularise its situation in accordance with the observations of the health technology unit, failing which the decision takes effect as of right.

Appeals against decisions of the Amt für Gesundheit (or the Amt für Lebensmittelkontrolle und Veterinärwesen) may be lodged with the Government within 14 days of notification; appeals against Government decisions go to the Verwaltungsgerichtshof (Administrative Court of Appeal) within 14 days.

Medical device market subjects have the right to appeal decisions of the institution empowered by the Minister of Health (VASPVT) under the procedure established by the Law on Administrative Proceedings of the Republic of Lithuania (Administracinių bylų teisenos įstatymas).

VASPVT refuses registration where the submitted documents are incomplete (or improperly formalised, or the device non conforming) and the person fails to remedy the indicated deficiencies within 30 days from receipt of the deficiency notice.

Unless a special law or regulation sets a longer or shorter period, an action before the administrative tribunal is no longer admissible after three months from the day the decision was notified to the applicant, or from the day the applicant could take knowledge of it (loi du 21 juin 1999 Art. 13(1)). A recours gracieux to the competent authority before that period expires suspends the contentieux period, which then starts again from notification of the new decision (Art. 13(2)). If more than three months pass after the recours gracieux without a new decision, the contentieux period starts at the end of the third month (Art. 13(3)). The date of the recours gracieux is proved by the notification of it or by a récépissé from the authority, which must be produced with the tribunal action (Art. 13(3)).

Unless there is péril en la demeure, an authority that proposes of its own motion to revoke or modify a decision that created or recognised rights, or to take a decision without an initiative from the person concerned, must tell that person by registered letter of the facts and law that lead it to act and must give at least eight days to submit observations, with a right to be heard in person if asked within that period (RGD 8 June 1979 Art. 9). A refusal of a request, a revocation or modification, a decision on recours gracieux, hiérarchique or de tutelle, and a decision that departs from a consultative opinion must be formally motivated (Art. 6). Appeal periods, administrative as well as contentieux, run only from communication of those reasons where motivation is required (Art. 7). A refusal or of office revocation must also indicate the appeal routes, the time limit, the body to which the appeal is addressed and how it is to be presented (Art. 14).

Administrative acts issued under Law 12/2025 (including registration decisions) may be appealed directly to the Administrative Court.

ISAF conducts a formal review of registration applications within 20 working days of receipt; incomplete applications trigger a notification to correct within a specified period, and failure to correct or lack of standing results in non acceptance; the same correction mechanism applies at substantive review, and the review clock is suspended during correction.

A person aggrieved by an Authority decision under sections 7, 9, 12, 14, 18, 22, 24, 30, 33, 35, 45 or 46 of Act 737 may appeal to the Minister: a copy of the notice of appeal must be sent to the Minister by registered post within thirty days of the decision, stating the appellant's particulars, the decision, the grounds and supporting documents, accompanied by the appeal fee (RM250 per Fifth Schedule); the Authority submits its reasons within 30 days, and the Minister may confirm, reverse or vary the decision, which is final and binding.

Query responses during evaluation are submitted in MeDC@St with a written response to each input request query, referencing uploaded file names (Class A: Section 10 'Any related information'; Class B/C/D: CSDT Misc section); the Authority may refuse registration on grounds including non provision of mandatory information within 30 working days, inaccurate classification, non medical device status, or revoked establishment licence.

Submissions to the Maltese competent authority are made on the Medicines Authority's medical device e forms: MT MDF02 for organisation registration, MT MDF05 for notification of medical devices made available on the local market, MT MDF03 for revision or withdrawal of a device registration, with incident reports filed on the health care professional and public incident report forms, and the Directorate reachable for guidance at devices.medicinesauthority@gov.mt. The Authority has separately noticed economic operators to register their organisation and to notify the devices they make available, both stated to be in line with S.L. 458.59. There is no appeal provision in the device regulations: S.L. 458.59 contains no reference to an appeal, a tribunal or a review of a decision, so a decision of the Authority is contested by the ordinary Maltese judicial review action. Under Article 469A of the Code of Organization and Civil Procedure (Cap. 12) the civil courts may enquire into the validity of an administrative act and declare it null, invalid or without effect where it violates the Constitution or is ultra vires on one of four grounds; the action must be filed within six months from the date the interested person became aware or could have become aware of the act, and the article does not apply where another law provides the mode of contestation. The Administrative Review Tribunal under the Administrative Justice Act (Cap. 490) is not that route: by Article 5(2) it has no general jurisdiction over administrative acts reviewable under Article 469A of Cap. 12 and reviews only classes of acts prescribed for it by or under the Act or another law.

Deficiency requests (prevención) in COFEPRIS trámites, and the applicant's deadline to cure them, are governed by Article 17 A, second paragraph, of the Ley Federal de Procedimiento Administrativo (as listed in the official ficha foundations); several device clocks carry positive silence (deemed approval) rules Class I registration (RIS Art. 179), modifications (RIS Art. 188) and prórrogas (RIS Art. 190 Bis 6) and the ficha records the ficta framework (LFPA Art. 17, second paragraph, and the 2011 RFTS Acuerdo, Art. Décimo primero).

Administrative acts issued under the notification and registration Procedure may be challenged by a prior complaint filed with the Agency within 30 days of the date of communication, under arts. 162 165 of the Administrative Code. Rejection of a dossier is reasoned in fact and in law; the reasons are recorded in the evaluation report and communicated to the applicant at the e mail address registered in the RSDM, together with a statement of the remedy available, the period for exercising it and the competent authority.

Communication between the applicant and AMDM takes place exclusively at the e mail address of the delegated responsible person and through the subdivision responsible for the regulation and registration of medical devices (idm@amdm.gov.md). Access to the personal cabinet is granted on the RSDM registration form completed and electronically signed by the administrator or director of the authorised representative and sent to that address, and AMDM grants access or communicates the reason for refusal within 10 working days of receipt.

An applicant may challenge an administrative act of the device regulator by filing a complaint for revision of whether the act is consistent with the law and its designated purposes. The complaint is filed with the higher level administrative body of the body that issued the act, or with an administrative body charged with reviewing and resolving complaints; where no such body exists it may be filed with the body that issued the act. It must be filed within 30 days of notification of the act, and must be resolved and answered within 30 days, extendable by the management official of the administrative body by up to 30 days with notice to the complainant.

Where a decision is taken to remove a laboratory diagnostic device from the register, the information is entered in the medical device electronic database within 1 working day; where a decision to reconsider (дахин хэлэлцүүлэх) is taken, the matter is considered by the Medical Device Council and the relevant sectoral council within 1 month of the required materials being submitted.

Operators must file an application with the Agency for every amendment or supplement to the data in the register before introducing the change. If the application to amend or supplement the registration is incomplete, the Agency notifies the applicant in writing to remedy the deficiencies and supply the requested data and documents within 30 days. The Agency issues the decision on the amendment or supplement of the registration within 60 days of the day of submission of the complete application. Amendments and supplements that do not affect the safety and performance of the device are notified to the Agency, and those are entered in the register without a decision being issued, with the applicant being informed. The Agency may verify the stated data and other data relevant to public health and give a negative opinion on the notified amendment or supplement.

The Agency enters into the register the medical device, the manufacturer, the legal person engaged in wholesale and retail trade in the medical device, and the importer, within 90 days of the day of submission of complete documentation. During the registration procedure the Agency may request from the applicant additional data needed to assess whether the conditions for registration are met. If the registration application is incomplete, the Agency notifies the applicant in writing to remedy the deficiencies and supply the requested data and documents within 30 days, and the 90 day period does not run until the requested data and documents are supplied. The Agency may, within the application procedure, verify the stated data and other data relevant to public health.

Any refusal of a device registration must be reasoned and notified to the applicant. The AMMPS publishes a 'Déposer un recours' channel on its site alongside its 'Déposer une réclamation' channel, giving applicants an administrative review route. Applications and all correspondence run through the AMMPS; the establishment's legal representative signs and stamps the file.

statement: Myanmar's Consumer Protection Law 2019 provides an administrative appeal channel. A person dissatisfied with an administrative order passed by the Office under s. 52 may appeal to the Committee concerned; a person dissatisfied with an administrative order passed by the Committee under s. 53, or with an order passed under s. 56(a), may appeal to the Commission, in each case within 30 days from the date the order was passed. On an appeal the Committee may confirm, amend or cancel the order of the Office, and the Commission may confirm, amend or cancel the order of the Committee or its own earlier decision; the Commission's decision is final and conclusive. This is the only appeal or review channel evidenced for a supplier of goods in Myanmar: no instrument of the Department of Food and Drug Administration providing for reconsideration, review or appeal of a medical device registration decision could be reached. · firstInstance: the Committee concerned (against an Office order under s. 52) · secondInstance: the Myanmar Consumer Protection Commission (against a Committee order under s. 53 or an order under s. 56(a)) · timeLimit: 30 days from the date of the order appealed against · finality: the decision of the Commission is final and conclusive

Decisions on clinical investigations with medical devices can be challenged through national routes: administrative appeal to the CCMO against a decision of an accredited MREC (medical research ethics committee), objection against a CCMO decision, and objection against negative validation of the investigation file.

Because WAND is a notification only system with no application decision, deficiency responses and appeal rights for market entry do not arise; Medsafe states notification does not mean or imply a device has been assessed for quality, safety, efficacy or performance. WAND access and submission problems are handled through devices@health.govt.nz.

Clients must comply with a NAFDAC Compliance Directive (CD) within 7 working days of issuance; failure to comply with any CD may result in cancellation of the application.

Delays caused by the client are not counted within the registration processing timelines.

Failure to respond promptly to NAFDAC queries or enquiries on an application (within ninety (90) days) will automatically lead to closure of the application.

Documentation in the device registration procedure is submitted in writing in one copy. Photocopies are accepted, provided the applicant files a written statement confirming that the copies match the originals. The application and its annexes are filed with MALMED on the prescribed form.

Individual decisions (enkeltvedtak) of Direktoratet for medisinske produkter may be appealed under the Public Administration Act § 28 to the immediately superior administrative organ (for a directorate, the ministry); the CA's clinical investigation pages expressly state that sponsors may appeal rejections of applications.

Medical device registration applications are filed through the online portal, and the applicant must first complete the initial approval of wholesale activity, local establishment approval and manufacturer registration, with the fee paid according to risk classification. An application made with the incorrect risk classification of a device may result in the re submission of the application under the appropriate risk class. The Drug Safety Center has the right to request more requirements according to the product type if needed, and a variation in a registered device must be filed through the variation services after registration is completed.

Under rule 60, an aggrieved person or party may prefer an appeal before the Appellate Board of the Authority against a decision of the MDB within sixty days. A fee for appeal is provided in Schedule C of the rules (PKR 50,000 as consolidated till April 2022; PKR 64,800 under S.R.O. 1399(I)/2025 row 132).

Sanctions imposed under Ley 90 are appealable by recurso de reconsideración and recurso de apelación, both granted in devolutive effect; resolution of the appeal exhausts the governmental avenue (vía gubernativa).

Registration applications for medical devices are treated as abandoned and finally closed by operation of law once twelve months have elapsed without the applicant pursuing the process.

The data entered in Annexes I, II, III and IV of Resolución DINAVISA N° 226/2024 has the status of a sworn declaration, which is the mechanism by which the applicant's own class declaration and modification notifications carry legal weight.

Where a device registration application is refused, the interested party may request a new registration procedure after paying the corresponding fee.

For device procedures, Reconsideración is filed and answered before the Director(a) Ejecutivo(a) of the Dirección de Dispositivos Médicos y Productos Sanitarios (max 15 business days to file, 15 to resolve); Apelación goes to the Director(a) General of DIGEMID (15 business days to file, 30 to resolve). Reconsideración requires new evidence; Apelación covers differing interpretation of evidence or pure law questions.

Where DIGEMID raises observations to documentation or technical information in inscripción/reinscripción, failure to cure them within a maximum of 30 business days from notification is a ground for suspension or cancellation of the registration.

FDA orders, rulings or decisions become final and executory fifteen (15) days after receipt by the adversely affected party unless an administrative appeal is perfected within that period; one motion for reconsideration may be filed and suspends the running of the period.

FDA orders, rulings or decisions are appealable to the Secretary of Health; an appeal is perfected upon filing the notice of appeal and posting the corresponding appeal bond; the appeal does not stay the decision unless the Secretary issues a stay order.

Applications with deficiencies are given a one time compliance period of a maximum of ninety (90) calendar days; non compliance means the application is disapproved; the applicant may re apply within sixty (60) calendar days after disapproval, with corresponding fee; unclaimed disapproved applications are destroyed after 90 calendar days.

An appeal from an opinion (opinia) of a bioethics commission lies to the Appellate Bioethics Commission (Odwoławcza Komisja Bioetyczna) at the Minister of Health.

A refusal of a clinical investigation application (or an application under Art. 29 30) is issued as a decision; the factual and legal justification is drawn up within 30 days of the decision, and the time limit for filing an appeal runs from the delivery of that justification.

Decisions on clinical investigation applications, notifications and substantial modifications may be challenged by administrative impugnation (hierarchical appeal to the member of Government responsible for health) and by judicial review under the general terms of law.

Decisions restricting, conditioning or prohibiting the placing on the market of devices must be reasoned and notified to addressees (to the registered e mail address, per the Administrative Procedure Code); such decisions may be appealed under the general terms.

Under Qatar's Law No. 6 of 2025 a licence application, or an application to renew one, is filed with the Ministry of Public Health's competent administrative unit (الإدارة) on the form prescribed for that purpose with the supporting documents; the Administration must decide the application within thirty days of submission and notify the applicant at its national address or by any means that gives knowledge. A refusal must be reasoned, and expiry of the thirty days without a reply is an implicit refusal of the application. The applicant may then appeal (يتظلم) to the Minister of Public Health within thirty days of being notified of the refusal; the Minister must decide the appeal within thirty days of its submission; expiry of that period without a reply is an implicit refusal of the appeal; and the Minister's decision on the appeal is final. The same procedure and the same time limits apply to applications for the licences under Articles 10, 12 and 13 of the law and to appeals against the administrative sanctions imposed under Article 35.

Authorisations, rejection decisions and suspensions for clinical investigations can be contested by the sponsor at ANMDMR within 30 days of receipt; a contestation commission (minimum 3 members not involved in the evaluation) meets within maximum 30 days, and the ANMDMR president's decision is communicated within maximum 7 days of the session; further appeal lies to the competent administrative courts.

If the clinical investigation dossier is incomplete or out of scope, ANMDMR sets a maximum 10 day term for the sponsor to transmit completions, extendable by maximum 20 days for complex information; failure to complete in time makes the request caduc (lapsed) without a separate decision; rejection decisions are communicated within maximum 5 days.

Where violations are identified during registration, the applicant is notified and must rectify them within a 30 day period; time to respond to that notification is excluded from the review clock; a dedicated official form 'Application for resumption of state registration of a medical device' exists.

On the Russian manufactured device route, the FGBU VNIIMT expertise query is sent once and must contain an exhaustive list of all questions; the applicant must respond within no more than 35 working days.

Rwanda gives an express, timed appeal against a decision of the Authority. Article 37 of the registration regulations provides: 'Any person aggrieved by a decision of the Authority may appeal to the Authority for review of the decision showing grounds for dissatisfaction within thirty (30) calendar days from the date of notice. The Authority shall, within forty five (45) calendar days from the date of receiving the application, review, reject or uphold its own decision according to applicable laws, and regulations. The applicant shall not be barred from appealing to the minister/ board of directors without applying to the Authority for review. If a person is dissatisfied with the decision after review, he/she may appeal to the supervising Authority whose decision shall be final.' The communications that precede an appeal are also codified. During assessment the Authority may request additional samples, documents, information, data or clarification; processing does not proceed until they are provided; failure to provide them within ninety (90) days of the date of request makes the application considered withdrawn; the applicant may request an extension of time in writing with reasons; and a fourth failure to provide satisfactory responses leads to rejection (art. 11). Where the Authority refuses to issue or amend a certificate of registration or notification it must notify the applicant in writing of the reasons for the refusal (art. 30), and any suspension must be effected on written notice setting out the reason for the proposed suspension, any corrective action required and the time within which it must be taken, and requiring the holder to show reasons in writing with evidence as to why the suspension should not be effected (art. 25). A holder may apply in writing to have a cancellation or suspension uplifted, and the Authority may review its decision within thirty (30) days of receiving the application (art. 27). The promotion regulations give a parallel route: an aggrieved person may apply to the Authority for review showing grounds for dissatisfaction within thirty (30) working days from the date of notice, the Authority must within fifteen (15) working days review, reject or vary its own decision, and if it still rejects the application the applicant shall appeal to the Board of Directors (CBD/TRG/017 Rev 1 art. 21). The vigilance guideline gives MAHs a written appeal against suspension or cancellation of a marketing authorisation within thirty (30) calendar days from the date of the Authority's notification; the grounds must be based on the information already submitted in the product's dossier and PSMF, additional or new information not earlier submitted will not be accepted, and the Authority may review or uphold its earlier decision (section 13.5).

Appeals against SFDA penalty decisions (Art. 42.1 of the Law) are heard by a Board formed Committee of at least 3 members including at least one legal advisor; the Committee's decisions may be appealed before the Administrative Court. Violations under Art. 42.2 are referred to the Public Prosecution and the competent court. Persons affected by violations may claim compensation before the competent court.

SFDA must notify the applicant of the reasons for refusal of an MDMA application, and the applicant may object to the refusal in accordance with the applicable legal procedures.

Senegal provides a general written channel for contesting or commenting on ARP action, but the device decree creates no dedicated appeal against its own decisions. The ARP operates a public 'RÉCLAMATIONS / SUGGESTIONS' form that any person can use: it records Date, the addressee chosen from a dropdown of every ARP directorate, service and unit — including 'Direction de l'Homologation et de la Sérialisation des Médicaments et autres Produits de Santé' with its 'Service des essais cliniques' and 'Service de l'homologation des médicaments, vaccins et autres produits de santé', 'Direction du Contrôle de la Qualité', 'Direction de l'Inspection Pharmaceutique, de la Surveillance du Marché et des Vigilances' and 'Direction des Affaires Juridiques / Service des études, de la législation et du contentieux' — the 'Nature de la déclaration' (Suggestion, Réclamation / Plaintes, Autres), contact fields (Nom / Prénom, Téléphone, E mail, Fonction / Entreprise) and a free text Message. The ARP also publishes a dedicated instrument, 'LIGNE DIRECTRICE POUR LES PLAINTES, RÉCLAMATIONS CONTRE LES DÉCISIONS RÉGLEMENTAIRES', in its official guideline library. Against that, Décret n° 2023 2419 contains no appeal article: art. 37 provides only that the regulation structure 'peut retirer, suspendre ou annuler une autorisation d'importation de dispositifs médicaux sur décision motivée'; art. 32 provides that the agrément 'peut faire l'objet de suspension ou de retrait en cas de manquement aux dispositions du présent décret' without stating a recourse; and art. 45 refers non compliance to the sanctions of the law on medicines and other health products. The only express recourse in the 2023 health products decrees is in Décret n° 2023 2424 art. 45: 'Les sanctions peuvent faire l'objet de recours suivant les conditions normales de droit commun.'

An appeal may be filed to the Ministry of Health against ALIMS decisions on registration and its amendments/renewal/removal, clinical trial approvals, pharmacopoeia compliance assessment, recognition of foreign documents and marks of conformity, technical assessment, product status determination, and import/export approvals. The Ministry's decision is final in the administrative procedure and an administrative dispute may be initiated against it. Entrusted tasks follow the general administrative procedure law unless the Law provides otherwise.

Persons affected by HSA decisions refusal of registration (s 30), imposition of conditions (s 32), reclassification (s 36), suspension or cancellation (s 37) may appeal in writing to the Minister within the time specified in the notice; the Minister's decision is final, and decisions take effect pending appeal unless the Minister directs otherwise.

ŠÚKL serves its deficiency notices and other outgoing documents (výzvy) on Slovak legal entities exclusively electronically to their seat address via www.slovensko.sk; Slovak natural persons receive them electronically only if their box is activated (otherwise paper conversion via Central Official Delivery), and foreign applicants without an activated box receive a paper copy of the electronic document. Follow up documents must quote the case number and handling officer.

JAZMP decides administrative matters at first instance under the general administrative procedure act (ZUP); appeals against JAZMP decisions are decided by the Ministry of Health.

Minor offences under ZMedPri 1 (60 listed violations, e.g. failing to provide the Slovenian IFU translation, not reporting data changes, lacking compliance/vigilance persons): fines EUR 800 4,000 for legal persons, 500 3,000 for sole traders, 200 1,000 for responsible persons, 100 500 for individuals; serious offences (78 listed, mainly substantive MDR/IVDR breaches incl. not reporting serious incidents to JAZMP): EUR 8,000 120,000 for legal persons, 5,000 50,000 sole traders, 500 5,000 responsible persons, 400 4,000 individuals.

A person aggrieved by a decision of the Council may lodge a written appeal within 30 days of being notified of the decision, to the Chairperson of the Council for attention the Registrar; the Registrar must within 30 days meet the appellant to try to resolve the matter, failing which the appellant may within 30 days (on payment of the prescribed fee) request the Minister to convene an appeal committee, which must decide within 30 days of its first hearing.

An advertiser disagreeing with a deliberation result may request re deliberation (재심의) to the self deliberation body within 30 days of notice; a person disagreeing with the re deliberation result may file an objection (이의신청) with the MFDS Commissioner within 30 days of notice.

During preliminary review (예비심사검토) of an application, missing attachment items may be submitted within 5 days.

Resolutions of AEMPS in the licence procedures of RD 192/2023 end the administrative route (ponen fin a la vía administrativa), so no ordinary administrative appeal (recurso de alzada) lies against them; the addressee may still use the optional reposición remedy or challenge the decision before the administrative courts.

If an application fails in the evaluation/committee process, the local agent can appeal for the registration.

Deficient documents or data are communicated to the applicant by email through the evaluation report; the applicant must submit the required deficient data or documents with the relevant payment within two months from the date of the email to the accepting point, failing which the application is given 'awaiting data' status.

Decisions under the national act may be appealed to a general administrative court (allmän förvaltningsdomstol); leave to appeal is required for appeal to the administrative court of appeal (kammarrätten). In practice, refused fee reductions have been appealed to Förvaltningsrätten.

Insofar as the Therapeutic Products Act does not provide otherwise, administrative procedure and legal protection are governed by the Federal Act of 20 December 1968 on Administrative Procedure (VwVG, SR 172.021), the Administrative Court Act and the Federal Court Act Swissmedic decisions follow the ordinary Swiss administrative justice track.

In clinical investigation procedures, the ethics committee confirms receipt of the application within 10 days and notifies formal deficiencies, setting a 10 day period to cure them (with notice that the application will not be entered upon if not corrected in time); the decision is issued within 40 days of confirmation of formally correct documents.

Against administrative fine decisions, the party may submit a written objection and request review within 15 days of delivery of the decision notice (once only); if unresolved, administrative appeal (訴願) and administrative litigation are available.

Applicants whose registration, filing or clinical trial applications are not approved may file one reconsideration request (申復) within four months of delivery of the decision, on procedural or technical grounds.

An applicant aggrieved by a TMDA registration decision may first make representations in writing to TMDA; if still unsatisfied with the decision, the applicant may appeal to the Minister responsible for Health.

A person aggrieved by a decision of the Authority may appeal to the Minister against that decision; the Authority may appear as respondent and be heard, and the Attorney General may intervene.

Refusals (non issuance or non renewal of establishment registration, licence, detailed listing receipt or notification receipt) may be appealed in writing to the Minister within 30 days of receiving notice; the Minister's decision is final, and for non renewal appeals the Minister may allow the operator to continue business pending decision.

When a detailed notification application is refused, the authority must send written notice to the applicant with the reasons and appeal rights within 15 days of the refusal order.

The ANMPS device technical dossier guide closes its document list with an express reservation: « Par nécessité, l'ANMPS se réserve le droit de demander d'autres documents que ceux décrits ci dessus. » A filer therefore cannot treat the published list as exhaustive, and a query or deficiency on a device dossier can lawfully extend to documents the guide does not name.

For clinical investigations, the sponsor may object to Kurum decisions (including validation/scope determinations) through the objection procedure established by the Kurum.

DAR/GDL/028 s. 4.9 provides the appeal route for devices: any objection to a decision of the registration in relation to any application for registration or listing of a surgical instrument or appliance can be submitted in writing to NDA, and after consideration of the representations NDA may approve registration or listing, or if not satisfied may reject the application. The statutory instrument supplies the procedural guarantees. Where NDA is not satisfied with the information provided in an application it must require the applicant to provide further information necessary to complete the application (reg. 38(3)), and where it does not accept an application it must communicate its decision and the reasons for refusal to the applicant (reg. 38(4)). Where NDA refuses to issue, amend or alter a certificate of registration it must notify the applicant in writing of the reasons for the refusal and give the applicant an opportunity to be heard (reg. 41(2)). On suspension, NDA must give written notice of intention setting out the reason, the corrective action required and the time within which it must be taken (reg. 31(3)(c)), and may not suspend before that time has elapsed or without giving the holder an opportunity to be heard (reg. 31(4)). DAR/GDL/028 s. 4.3.1 adds a procedural sanction for silence: once a query or request has been raised the processing halts until a response is received, and if no response is received within six months from the written query notification date the application may be cancelled or rejected.

Written/electronic appeals to Держлікслужба must be reviewed within one month (15 days for simple matters, absolute cap 45 days); a complaint against actions or inaction of a state body may be filed under subordination with a higher body or official, without prejudice to court review.

Держлікслужба may leave a register notification without consideration where it is submitted by an unauthorized person, lacks required data, contains data inconsistent with the attached documents, documents violate electronic document formatting requirements, or required documents are missing; resubmission is possible after remedying deficiencies.

A person affected by any decision issued under Decree Law 38/2024 may file a grievance before the Grievance Committee (formed by decision of the Chairman, Minister or head of the local health authority) within 15 days of becoming aware of the decision; the Committee must decide within 30 days by reasoned decision; silence is deemed rejection; the grievance decision is final.

MHRA has appointed the Chartered Institute of Arbitrators (CIArb) as its dispute resolution service for: clinical investigation notifications (UK MDR regs 16 and 29), refusals of clinical investigation and performance study applications in Northern Ireland, notified body or UK approved body designation decisions (reg 45), and applications for exceptional use of non complying devices (regs 12, 26 and 39); CIArb does not handle administrative complaints.

A person served with an enforcement notice under the Medicines and Medical Devices Act 2021 may apply to court to revoke or vary the notice within 28 days of the notice being served to a magistrates' court (England and Wales), the sheriff (Scotland), or a court of summary jurisdiction (Northern Ireland).

A PMA applicant who receives a not approvable letter or an order denying approval may request administrative review under section 515(d)(4) and (g) of the FD&C Act, as referenced in 21 CFR 814.40(a).

Applicants answer MSP observations within the 90 day cure window (Art. 11); under the MSP manual, once first observations are issued the company has a maximum of 3 months to lift them or the application restarts as new, and three or more observation rounds lead MSP to consider rejecting the product; an FO 13222 017 form allows requesting prioritisation of product evaluation.

Before sanctions under Decreto 3/008 are applied (fines from a minimum of 30 Unidades Reajustables, suspension up to permanent cancellation of registration, annulment and criminal referral in case of fraud), the company is granted a period of 10 working days (vista) to respond.

The applicant has the right to complain, in the established procedure, against refusal of registration and against actions (inaction) of officials of the Centre. Refusal of registration is allowed only on the exhaustively listed grounds (uncured 60 day deficiencies, unreliable/false information, previously used samples, substantiated negative conclusions of laboratory/clinical/inspection/expert evaluations); refusal on other grounds, including inexpediency, is not allowed.

Deficiency notices are sent through the information system with 30 working days to cure acceptance stage deficiencies (failure leads to a refusal decision, after which a new application is treated as newly filed) and 60 working days for specialized expertise deficiencies; the certificate (Annex 4 form) or a reasoned refusal is sent to the applicant within 2 working days of the decision.

Decree 98 designates the authority competent to resolve Class C/D registration dossiers in a dedicated article (Art. 30); since 22/11/2025 this authority is IMDA.

statement: ZAMRA screens an application before evaluation. Where deficiencies are identified during screening of a non IVD application, a request for additional information is made to the applicant, who must supply it within a period specified by the Authority but not exceeding 60 days; failure to respond, or an incomplete, deficient or immaterial response, results in rejection, and the applicant is informed in writing. For IVDs, where the applicant fails to submit additional information within the stipulated time the Authority closes the application, and if the applicant wishes to resubmit, the application is processed as a new application. Evaluation of an IVD application that the Technical Committee defers for unresolved safety or quality issues is refused if the required data is not provided within 90 days. An applicant aggrieved by a decision on its application may seek redress in accordance with the Act (non IVD s.1(m)): under section 56 of the Act a person aggrieved by a decision of the Authority may appeal to the Minister within thirty days, the Minister must decide within ninety days, and a further appeal lies to the High Court within thirty days.

Part VII of the Medicines and Allied Substances Control Act gives any person aggrieved by a decision of the Authority in terms of the Act a right of appeal to the Administrative Court, exercised by notice in writing filed within 30 days after the date of the decision. It is the general statutory remedy and it is unqualified as to the kind of decision or the kind of product, so a refusal or a condition laden approval in the device instruments falls to be challenged there. The device instruments prescribe no review, reconsideration or appeal procedure of their own: the Condom Regulations 2005 and the Gloves Regulations 2006 provide for approval of a type and brand (and separately of each batch) but create no internal challenge route against the Authority's decision.